DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Cancellation of claims 21-26 and 28-37 is acknowledged. Applicant’s election without traverse of invention 1 (claims 1-20 and 27) in the reply filed on 02/02/2026 is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 and 27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 10-16 recites the limitation "the menstrual fluid passage". There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, claims 10-16 will be assumed to depend on claim 9.
The term “substantially proximate” in claims 1, 9, and 17 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. “Substantially” renders the term “proximate” indefinite.
The term “substantially” in claims 8 and 16 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. “Substantially” renders the term “simultaneous” indefinite.
Claim 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 11 recites the limitation “at least one tine is resilient”. It is unclear within the scope of the claims what “resilient” refers to. For the purposes of examination, resilient will be interpreted as bendable, per applicant’s specification para [0117]: “the material may be resilient such that the fins may be bent into the open configuration” and para [0118].
Claims 2-7, 18-20, and 27 are rejected due to dependency.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ealovega et al. (US 20170325788 A1, as cited by applicant’s IDS filed 03/28/2023) in view of Shaviv et al. (US 20250177191 A1).
Regarding claim 1, Ealovega discloses a female urinary device (title, abstract) comprising: a urine stream collection passage having a stream collection opening and a discharge opening ([0133]: " discharging urine… collection container having a discharge opening and a collection opening (FIG. 9, Block 900), "), the stream collection opening being sized and shaped so as to contact tissue of the vulva substantially proximate the urethral opening forming a seal to surround and isolate a urethral opening ([0068]: "having a shape designed to accept urine-flow and also designed to surround and isolate the female urethral opening and therefore also the urine-stream from contact with anything other than the interior of said FUD device by forming a seal with the tissue immediately surrounding said urethral opening ") and a placement probe connected to urine stream collection passage and being sized and shaped for interior engagement with a vaginal opening ([0103]: “includes a probe or vaginal insert protrusion (25) configured for interior engagement with a vaginal opening for placement of the collection opening (24) relative to the urethral opening”).
Ealovega fails to disclose wherein a distal end of the placement probe is configured to expand between a closed configuration, for insertion into the vaginal opening, and an open configuration, that anchors the placement probe within the vagina and that seats and maintains the seat of the stream collection opening relative to the urethral opening.
Shaviv discloses a female urinary device (title, abstract) wherein a distal end of a placement probe is configured to expand between a closed configuration ([0041]: “an element is actuated to apply a force on the axially extending ribs, thereby causing them to move radially outwardly at the device distal end.”), for insertion into the vaginal opening ([0041]: “against a wall of the vaginal cavity.”), that anchors the placement probe within the vagina and that seats and maintains the seat of the stream collection opening relative to the urethral opening. ([0041]: “to move radially outwardly at the device distal end whereby, optionally, a at least the device distal end achieves a seal against a wall of the vaginal cavity.”, [0069]: “so that it does not move downward in the vaginal canal. To that end, the bias of the stretched vaginal wall will prevent the device from moving downward in the vaginal canal.” Fig 1A, wherein the device is anchored in place relative to the urethral opening).
It would have been obvious to a person of ordinary skill in the art prior to an effective filing date to modify the device disclosed by Ealovega to include the expansion of a distal end of the menstrual fluid passage between a closed configuration, for insertion into the vaginal opening, and an open configuration, for collection of the menstrual fluid and to effect alignment of the stream collection opening relative to the urethral opening as disclosed by Shaviv in order to improve comfort during insertion of the device (Shaviv [0084]).
Regarding claim 2, Shaviv further discloses wherein the distal end includes at least one tine configured to expand between an open configuration and a closed configuration for anchoring the placement probe within the vagina (Fig 6, [0119]: “arms”).
Regarding claim 3, Shaviv discloses wherein the at least one tine is resilient ([0066]: “provided by the elasticity of the axially extending elements.”)
Regarding claim 4, Shaviv discloses wherein the distal end includes a thin synthetic elastic sleeve configured to effect a bias for closing the placement probe. ([0036]: “a rim is formed at the device distal end by at least a membrane which is stretched by the axially extending elements”).
Regarding claim 5, Shaviv discloses wherein the distal end of the placement probe is a collapsible elastic material ([0059]: “ribs and/or the membrane may be formed of, for example, Nylon12™, polypropylene, or from a biodegradable polymer PLA or of any suitable member of the polyolefin family such as, for example, polycarbonate or polyurethane, optionally having a Young's modulus in the range of from 0.1-50.0 MPa”).
Regarding claim 6, Shaviv discloses wherein the female urinary device further includes an expansion actuator effecting expansion of the distal end of the placement probe ([0109]: “Actuator element 512 is then positioned relative to ribs 502 such that radial portion 522 of actuator 512”).
Regarding claim 7, Shaviv discloses wherein the expansion actuator forms at least a portion of a menstrual fluid passage ([109]: “Actuator element 512 is then positioned relative to ribs 502 such that radial portion 522 of actuator 512 is disposed between rib distal ends 514a. Since the outer diameter of flange 524 is wider than D, the actuator may optionally rest on the rib distal ends 514a”, [0030]: “collection of menses discharge”), wherein a tip of the expansion actuator includes an opening which forms a menstrual discharge opening for collection of menstrual fluid (Fig 5A to 5B, element 512).
Regarding claim 9, Ealovega discloses a female urinary device (title, abstract) comprising: a urine stream collection chamber having a stream collection opening and a discharge opening ([0134]: "includes a urine stream collection chamber 23″ having a urine discharge opening (28′) and a urine stream collection opening (24′)"), the stream collection opening being sized and shaped so as to contact tissue of the vulva substantially proximate the urethral opening forming a seal to surround and isolate a urethral opening ([0134]: "the urine stream collection opening (24′) being configured to surround and isolate a urethral opening"); and a menstrual fluid passage coupled to the urine stream collection chamber ([0135]: " a menstrual fluid passage (45′).”), the menstrual fluid passage having a menstrual fluid discharge opening and a menstrual fluid collection opening ([0135]: “The menstrual fluid passage (45′) including a menstrual fluid discharge opening (46′) and a menstrual fluid collection opening "), the menstrual fluid passage being isolated from the urine stream collection chamber ([0135]: “the menstrual fluid passage (45′) is isolated from the urine stream collection chamber).
Ealovega fails to disclose wherein a distal end of the menstrual fluid passage is configured to expand between a closed configuration, for insertion into the vaginal opening, and an open configuration, for collection of the menstrual fluid and to effect alignment of the stream collection opening relative to the urethral opening.
Shaviv discloses a female urinary device (title, abstract) wherein a distal end of a menstrual fluid passage is configured to expand between a closed configuration ([0041]: “an element is actuated to apply a force on the axially extending ribs, thereby causing them to move radially outwardly at the device distal end.”), for insertion into the vaginal opening ([0041]: “against a wall of the vaginal cavity.”), and an open configuration ([0041]: “to move radially outwardly at the device distal end whereby, optionally, at least the device distal end achieves a seal”), for collection of the menstrual fluid ([0030]: “the collection of menses discharge”, [0101-0102]).
It would have been obvious to a person of ordinary skill in the art prior to an effective filing date to modify the device disclosed by Ealovega to include the expansion of a distal end of the menstrual fluid passage between a closed configuration, for insertion into the vaginal opening, and an open configuration, for collection of the menstrual fluid and to effect alignment of the stream collection opening relative to the urethral opening as disclosed by Shaviv in order to improve comfort during insertion of the device (Shaviv [0084]).
Ealovega further discloses and effecting alignment of the stream collection opening relative to the urethral opening ([0182]: “inserting the integrated interface into the vaginal opening, effecting alignment of the urine stream collection opening with a urethra,”, wherein alignment is affected by insertion of the device).
Regarding claim 10, Shaviv further discloses wherein the distal end includes at least one tine configured to expand between an open configuration and a closed configuration for anchoring the menstrual fluid passage within the vagina (Fig 6, [0119]: “arms”).
Regarding claim 11, Shaviv discloses wherein the at least one tine is resilient ([0066]: “provided by the elasticity of the axially extending elements.”)
Regarding claim 12, Shaviv discloses wherein the distal end includes a thin synthetic elastic sleeve configured to effect a bias for closing the menstrual fluid passage ([0036]: “a rim is formed at the device distal end by at least a membrane which is stretched by the axially extending elements”).
Regarding claim 13, Shaviv discloses wherein the distal end of the menstrual fluid passage is a collapsible elastic material ([0059]: “ribs and/or the membrane may be formed of, for example, Nylon12™, polypropylene, or from a biodegradable polymer PLA or of any suitable member of the polyolefin family such as, for example, polycarbonate or polyurethane, optionally having a Young's modulus in the range of from 0.1-50.0 MPa”).
Regarding claim 14, Shaviv discloses wherein the female urinary device further includes an expansion actuator effecting expansion of the distal end of the menstrual fluid passage ([0109]: “Actuator element 512 is then positioned relative to ribs 502 such that radial portion 522 of actuator 512”).
Regarding claim 15, Shaviv discloses wherein the expansion actuator forms at least a portion of the menstrual fluid passage ([109]: “Actuator element 512 is then positioned relative to ribs 502 such that radial portion 522 of actuator 512 is disposed between rib distal ends 514a. Since the outer diameter of flange 524 is wider than D, the actuator may optionally rest on the rib distal ends 514a”), wherein a tip of the expansion actuator includes an opening which forms a menstrual discharge opening for collection of menstrual fluid (Fig 5A to 5B, element 512).
Regarding claim 16, Ealovega discloses wherein the female urinary device provides substantially simultaneous passage through the menstrual fluid passage and urine stream collection chamber to effect discharge of the menstrual fluid from the menstrual fluid passage through a menstrual fluid discharge opening and discharge of urine from the urine stream collection chamber through one or more of the urine discharge opening and a spillway ([0182]: “providing substantially simultaneous passage through the menstrual fluid passage and urine stream collection chamber to effect discharge of the menstrual fluid from the menstrual fluid passage through the menstrual fluid discharge opening and discharge of urine from the urine stream collection chamber through one or more of the urine discharge opening and a spillway.”).
Regarding claim 17, Ealovega discloses a method of collecting urine with a female urinary device, the method comprising (title, abstract) comprising: providing a urine stream collection chamber having a stream collection opening and a discharge opening ([0133]: " discharging urine… collection container having a discharge opening and a collection opening (FIG. 9, Block 900), "), the stream collection opening being sized and shaped so as to contact tissue of the vulva substantially proximate the urethral opening forming a seal to surround and isolate a urethral opening ([0068]: " an entrance-portal (24) having a shape designed to accept urine-flow and also designed to surround and isolate the female urethral opening and therefore also the urine-stream from contact with anything other than the interior of said FUD device by forming a seal with the tissue immediately surrounding said urethral opening"); effecting anchoring within the vagina with a placement probe connected to urine stream collection passage and being sized and shaped for interior engagement with a vaginal opening ([0103]: “includes a probe or vaginal insert protrusion (25) configured for interior engagement with a vaginal opening for placement of the collection opening (24) relative to the urethral opening”).
Ealovega fails to disclose wherein a distal end of the placement probe is configured to expand between a closed configuration, for insertion into the vaginal opening, and an open configuration, that anchors the placement probe within the vagina and that seats and maintains the seat of the stream collection opening relative to the urethral opening.
Shaviv discloses a female urinary device (title, abstract) wherein a distal end of a placement probe is configured to expand between a closed configuration ([0041]: “an element is actuated to apply a force on the axially extending ribs, thereby causing them to move radially outwardly at the device distal end.”), for insertion into the vaginal opening ([0041]: “against a wall of the vaginal cavity.”), that anchors the placement probe within the vagina and that seats and maintains the seat of the stream collection opening relative to the urethral opening. ([0041]: “to move radially outwardly at the device distal end whereby, optionally, a at least the device distal end achieves a seal against a wall of the vaginal cavity.”, [0069]: “so that it does not move downward in the vaginal canal. To that end, the bias of the stretched vaginal wall will prevent the device from moving downward in the vaginal canal.” Fig 1A, wherein the device is anchored in place relative to the urethral opening).
It would have been obvious to a person of ordinary skill in the art prior to an effective filing date to modify the device disclosed by Ealovega to include the expansion of a distal end of the menstrual fluid passage between a closed configuration, for insertion into the vaginal opening, and an open configuration, for collection of the menstrual fluid and to effect alignment of the stream collection opening relative to the urethral opening as disclosed by Shaviv in order to improve comfort during insertion of the device (Shaviv [0084]).
Regarding claim 18, Shaviv further discloses providing at least one tine at the distal end configured to expand between the open configuration and the closed configuration for anchoring the placement probe within the vagina (Fig 6, [0119]: “arms”).
Regarding claim 19, Shaviv discloses providing collapsible elastic material at the distal end configured to expand between the open configuration and the closed configuration for anchoring the placement probe within the vagina ([0059]: “ribs and/or the membrane may be formed of, for example, Nylon12™, polypropylene, or from a biodegradable polymer PLA or of any suitable member of the polyolefin family such as, for example, polycarbonate or polyurethane, optionally having a Young's modulus in the range of from 0.1-50.0 MPa”).
Regarding claim 20, Shaviv discloses effecting expansion of the distal end of the placement probe with an expansion actuator ([0109]: “Actuator element 512 is then positioned relative to ribs 502 such that radial portion 522 of actuator 512”).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ealovega in view of Shaviv as applied to claim 1 above, and further in view of Schwartz (US 20210330369 A1) .
Regarding claim 27, Ealovega as modified by Shaviv discloses the device of claim 1, but fails to disclose wherein the urine stream collection container has a viewing aperture through which placement of the stream collection opening relative to the urethral opening is observed.
Schwartz discloses a urine stream collection container that has a viewing aperture through which placement of the stream collection opening relative to the urethral opening is observed ([0048]: “a Female Urinary Collection Device 6. 9 with cameras 12 and optical 12 viewing devices for accurate placement to fit the contours of the vulva 11 and female anatomy 11.”, Fig 2).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the device disclosed by Ealovega as modified by Shaviv to include the viewing aperture disclosed by Schwartz in order to improve the accuracy of placement of the device (Shwartz [0048]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Doreswamy et al. (US 20190240063 A1) – discloses a urine collection device that expands
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/KAVYA SHOBANA BALAJI/ Examiner, Art Unit 3791
/DANIEL L CERIONI/ Primary Examiner, Art Unit 3791